The 2001 anthrax emergency in the United States has prompted public health authorities to consider how they might conduct mass immunization campaigns if confronted by a bioterrorism event. The anthrax vaccine now used in the United States requires six subcutaneous injections over an 18-month period, plus yearly boosters. We propose to develop a new, nasally administered, extended-release anthrax vaccine for use as primary or booster immunizations. Our nasal formulation for anthrax antigen will have several important advantages: it will (1) allow easy, non-invasive administration; (2) improve the immune response and reduce the number of shots; (3) be bioadhesive, with a longer residence time because the formulation will be able to adhere to the posterior portion of the nose, where mucociliary activity results in faster clearance of medications and thus increases the bioavailability of the vaccine; (4) increase antigen delivery, enhance antigen stability, and act as an antigen reservoir or depot; and (5) eliminate the need for alum as an adjuvant. The proposed formulation will be a polymer-based, two-part formulation that will be mixed in a hand-held delivery device just prior to administration. (The delivery device is beyond the scope of this project, although such devices have already been used for other vaccines). The study will involve collaborative studies by investigators with expertise in pharmaceutical formulation, vaccine biology, and immunology. The long-term goal is a fast-acting, easily administered, extended-release anthrax vaccine. [unreadable] [unreadable]